UL54

This study is a multi-center, global, open-label, Phase 1b/2 clinical study, and it will be conducted at multiple study sites in several countries, including Japan, Korea, and Singapore, to reveal the safety, tolerability, dose limiting toxicity (DLT), maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D), pharmacokinetics (PK), and preliminary efficacy of BCV in patients with relapsed or refractory lymphoma and to assess the efficacy and safety of Brincidofovir (SyB V-1901, BCV) in patients with relapsed or refractory Extranodal Natural Killer/T-cell Lymphoma (ENKL).
This study consists of 2 parts and will enroll a total (maximum) of 43 male and female participants who meet the eligibility criteria (Phase 1b part: Up to 18 participants [3 to 6 participants in each of the 3 cohorts], Phase 2 part: 25 participants).

The primary objective of this clinical trial is to evaluate the efficacy of liposomal bupivacaine and ropivacaine in the treatment of pain associated with herpes zoster (shingles). This trial will also assess the safety profiles of both liposomal bupivacaine and ropivacaine.
The study aims to address the following key questions:
Does nerve blockade with liposomal bupivacaine or ropivacaine reduce the required dosage of gabapentin in participants? What medical issues, if any, arise in participants undergoing paravertebral block, intercostal nerve block, RISS (Radiofrequency Intervention for Spinal Segment); or pulsed radiofrequency (PRF)? Can nerve blocks, specifically paravertebral block, intercostal nerve block, RISS; and PRF, effectively treat severe postherpetic neuralgia (PHN)? The study will compare these interventions.
Study Procedures:
Participants will:Receive ultrasound-guided nerve blocks or pulsed radiofrequency every 48 hours, for a total of 3 treatments.
Undergo assessments, either in-person or via telephone, at the following time points: before therapy (baseline), on the day of treatment (Day 1), Day 7, Day 30, and Day 90 post-treatment.
Have their symptoms recorded, along with their scores on the Numerical Rating Scale (NRS) and the Zoster Brief Pain Inventory (ZBPI).

主要研究目的 研究空腹和餐后状态下口服受试制剂（T）泛昔洛韦片（规格：0.25 g，浙江四维医药科技有限公司生产，浙江车头制药股份有限公司提供）与参比制剂（R）泛昔洛韦片（商品名：Famvir，规格：250 mg，Phoenix Labs持证，浙江车头制药股份有限公司提供）在健康成年受试者体内的药代动力学，评价两种制剂的生物等效性。 次要研究目的 评价中国健康受试者空腹和餐后状态下口服受试制剂（T）泛昔洛韦片和参比制剂（R）泛昔洛韦片（Famvir）后的安全性。